FDA Inspection
Teva Pharmaceutical Industries Ltd.Teva Pharmaceutical Industries Ltd. – FDA Inspection, May 23, 2023
Record Details
This FDA Inspection record concerns Teva Pharmaceutical Industries Ltd., with an inspection on May 23, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 0571d0c0-bd92-486e-add6-268f4e519233
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1207104
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.67(b)(6)Cleaning SOP/inspection
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.67(b)(6)Cleaning SOP/inspection
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Other FDA inspections of Teva Pharmaceutical Industries Ltd.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 22, 2019 | Not classified | Office of Inspections and Investigations | |
| July 25, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 25, 2017 | Not classified | Office of Inspections and Investigations | |
| June 15, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 18, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Teva Pharmaceutical Industries Ltd.
- FDA Inspection 1111726 - 2019-09-22
- FDA Inspection 1099394 - 2019-07-25
- FDA Inspection 1016187 - 2017-05-25
- FDA Inspection 935223 - 2015-06-15
- FDA Inspection 849301 - 2013-07-18
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